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D-0261-2022 Class II Terminated

Recalled by ASP CARES — San Antonio, TX

FDA drug recall D-0261-2022 was initiated by ASP CARES on Nov 17, 2021 and is designated Class II. Reason for recall: Lack of Assurance of Sterility The recall status is terminated (terminated Dec 2, 2022). Affected quantity: 896 vials.

Recall Details

Product Type: Drugs
Report Date: Dec 8, 2021
Initiation Date: Nov 17, 2021
Termination Date: Dec 2, 2022
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 896 vials

Product Description

Biotin Solution for Injection, 10 mg/mL, 30 mL Multiple Dose Vial, Sterile, For IM or IV use only, Rx only ASP Cares, 2414 Babcock Rd Ste #106, San Antonio, TX 78229 NDC 72833-0589-30

Reason for Recall

Lack of Assurance of Sterility

Distribution Pattern

United States

Code Information

Lot: 091721589 BUD: 03/16/2022

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-0261-2022
openFDA file date: Nov 3, 2026
Loaded by RegDataLab: Nov 4, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.